FDA Inspection
Lusochimica S.p.A.Lusochimica S.p.A. – FDA Inspection, Oct 30, 2015
Record Details
This FDA Inspection record concerns Lusochimica S.p.A., with an inspection on October 30, 2015, issued by the Center for Drug Evaluation and Research, covering drugs.
- Company
- Lusochimica S.p.A.
- Inspection Date
- October 30, 2015
- Product Type
- Drugs
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ID · e5876a8a-a78e-4045-b3da-ba36f53d6b53
Inspection Facts
Voluntary Action Indicated (VAI)
Objectionable conditions were found, but FDA is not prepared to take or recommend regulatory action.
- Inspection number
- 955455
- FDA center
- Human Drugs
- Project area
- Drug Quality Assurance
FDA Citations
6- 21 CFR 211.42(a)Buildings of Suitable Size, Construction, Location
- 21 CFR 211.100(b)Procedure Deviations Recorded and Justified
- 21 CFR 211.194(a)(8)Second person sign off
- 21 CFR 211.113(a)Procedures for non-sterile drug products
- 21 CFR 212.30(b)Equipment procedures overall
- 21 CFR 212.60(d)Supplies adequately controlled
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Other FDA inspections of Lusochimica S.p.A.
3| Date | Classification | Office | Project area |
|---|---|---|---|
| December 3, 2021 | VAI | Center for Drug Evaluation and Research | Drug Quality Assurance |
| August 3, 2018 | VAI | Center for Drug Evaluation and Research | Drug Quality Assurance |
| December 15, 2011 | VAI | Center for Drug Evaluation and Research | Drug Quality Assurance |
Other documents for Lusochimica S.p.A.
- FDA Inspection 1211546 - 2021-12-03
- FDA Inspection 1063472 - 2018-08-03
- FDA Inspection 760016 - 2011-12-15
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